Quality management

1
Basic Principles of GMP
Quality Management
Part One
2
Quality Management

• Objectives
• To understand key issues in quality
  assurance/quality control.
• To understand specific requirements on
  organization, procedures, processes and
  resources.
• To develop actions to resolve your current
  problems.

3
Quality Management

• Quality Management
• Determines and implements the quality policy
• The basic elements are
• an appropriate infrastructure or quality system
  encompassing the Procedures, Processes, and
  Resources
• the systematic actions necessary to ensure
  adequate confidence that a product (or service)
  will satisfy given requirements for Quality
• The totality of these actions is termed Quality
  Assurance

Part One
4
Quality Management

• Quality Management
• Terminology may differ
• Quality System is said to be rarely used in
  drug manufacturing
• The concepts of QA, GMP and Quality Control are
  interrelated aspects of Quality Management.
• They are described on the following slides in
  order to emphasize their relationship and their
  fundamental importance to the production and
  control of pharmaceutical products

Part One
5
Quality Management

• Principles of Quality Assurance
• Wide-ranging concept
• covers all matters that individually or
  collectively influence the quality of a product
• Totality of the arrangements
• to ensure that the drug is of the right quality
  for the intended use
• Quality Assurance incorporates GMP
• and also product design and development which is
  outside the scope of this module

Part One 1.1
6
Quality Management

• Requirements for QA Systems I
• 1. Ensure products are developed correctly
• 2. Identify managerial responsibilities
• 3. Provide SOPs for production and control
• 4. Organize supply and use of correct starting
  materials
• 5. Define controls for all stages of manufacture
  and packaging

Part One 1.2 a-j
7
Quality Management

• Requirements for QA Systems II
• 6. Ensure finished product correctly processed
  and checked before release
• 7. Ensure products are released after review by
  authorized person
• 8. Provide storage and distribution
• 9. Organize self-inspection

Part One 1.2 a-j
8
Quality Management

• GMP
• Ensure that products are consistently produced
  and controlled
• Diminishes risks that cannot be controlled by
  testing of product
• Cross-contamination
• Mix-ups

Part One 2.1 a-j
9
Quality Management

• Basic Requirements for GMP I
• 1. Clearly defined and systematically reviewed
  processes
• 2. Critical steps validated
• 3. Appropriate resources personnel, buildings,
  equipment, materials
• 4. Clearly written procedures
• 5. Trained operators

Part One 2.1 a-j
10
Quality Management

• Basic Requirements for GMP II
• 6. Complete records, failure investigations
• 7. Proper storage and distribution
• 8. Recall system
• 9. Complaint handling

Part One 2.1 a-j
11
Quality Management

• Group session - I
• How many GMP deficiencies can you find in the
  photographs in the handout?

12
Quality Management

• Quality relationships
• Quality Management
• Quality Assurance
• GMP
• Quality Control

Part One 1, 2 and 3
13
Quality Management

• Quality Control (QC)
• QC is part of GMP

14
Quality Management

• Quality Control (QC) Department
• Each holder of a manufacturing authorization
  should have a QC Department
• Independence from production and other
  departments is considered to be fundamental
• Under the authority of an appropriately qualified
  and experienced person with one or several
  control laboratories at his or her disposal.

Part One 3.2
15
Quality Management

• Basic Requirements for Quality Control
• Resources
• Adequate facilities
• Trained personnel
• Approved procedures

Part One 3.2
16
Quality Management

• Basic Requirements for Quality Control
• Tasks
• Sampling
• Inspecting
• Testing
• Monitoring
• Releasing/rejecting

Part One 3.2
17
Quality Management

• Basic Requirements for Quality Control - I
• Objects
• Starting materials
• Packaging materials
• Intermediates
• Bulk products
• Finished products
• Environmental conditions

Part One 3.2
18
Quality Management

• Basic Requirements for Quality Control II
• 1. Sampling approved by QC department
• 2. Validated test methods
• 3. Records
• 4. Review and evaluation of production
  documentation
• 5. Failure investigations for all deviations
• 6. Ingredients comply with the marketing
  authorization

Part One 3.2 b e
19
Quality Management

• Basic Requirements for Quality Control III
• 7. Ingredients are of the required purity
• 8. Proper containers
• 9. Correct labelling
• 10. Release of batches by the authorized person
• 11. Retained samples of starting materials and
  products

Part One 3.2 e h
20
Quality Management

• Other Duties of the Quality Control Department
• 1. Establish QC procedures
• 2. Reference standards
• 3. Correct labelling
• 4. Stability testing
• 5. Complaint investigations
• 6. Environmental monitoring

Part One 3.3
21
Quality Management

• Assessment of Finished Products
• Should embrace all relevant factors. For example
• production conditions
• in-process test results
• manufacturing documentation
• compliance with finished product specification
• examination of the finished pack

Part One 3.4
22
Quality Management

• QC Access
• QC Personnel MUST have access to production areas
  for sampling and investigation
• As appropriate!

Part One 3.5
23
Quality Management

• Quality Control - summary
• QC is part of GMP - refer to the handout
• sampling
• specifications
• testing
• release procedures
• recalls and complaints
• decision-making in all
• quality matters

• authorization
• definition of product quality
• laboratory operations
• release decisions
• investigation and reporting

Part One 3.1, 3.2
24
Quality Management

• Group session II
• Imagine you are inspecting a pharmaceutical
  company for compliance with GMP
• Consider the situations in the next slides which
  may impact on a companys quality management
  programme.
• Describe the action to be taken in each case

25
Quality Management

• Issues I
• Quality Management manual not established in
  writing
• Limited human resources
• Lack of qualified people
• Processes not properly validated
• Poor SOPs or standard batch documentation
• More consideration to cost than quality
• Family members in key positions of authority

26
Quality Management

• Issues II
• Substandard materials deliberately purchased
• Technical staff not involved in purchasing
• Inability to re-export substandard materials
• Owner insists on selling rejects
• Corruption
• No commitment to training